(194 days)
The Harbor MedTech BriDGE Extracellular Collagen Matrix Wound Dressing is indicated for the local management of moderately to heavy exuding wounds, including:
- Partial and full thickness wounds, .
- Draining wounds, .
- Pressure sores/ulcers. .
- Venous ulcers, ●
- Chronic vascular ulcers, .
- Diabetic ulcers, .
- Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears),
- Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric . wounds, dehisced surgical incisions)
The Harbor MedTech BriDGE Extracellular Collagen Matrix (ECM) Wound Dressing is a decellularized equine pericardial device that has been stabilized and radiation sterilized. The BriDGE ECM is non-pyrogenic and is provided sterile for single use only. The device must be rehydrated and rinsed prior to use following the procedure described in the Instructions for Use.
The BriDGE ECM is available in four sizes. The BriDGE ECM is available as a standard dressing and in a fenestrated model with pre-cut slits in the collagen matrix.
The provided text describes the acceptance criteria and study for the Harbor MedTech BriDGE Extracellular Collagen Matrix Wound Dressing.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the BriDGE Extracellular Collagen Matrix Wound Dressing were primarily established through biocompatibility testing and material testing (tensile strength and suture pull-out testing) to demonstrate substantial equivalence to predicate devices. The reported device performance is indicated by the "Pass" status for biocompatibility tests and comparative results for material testing.
| Test Category | Specific Test | Acceptance Criteria (Implied by "Pass" or "Equivalent/Stronger") | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (ISO Elution Method) | Non-toxic | Pass - non-toxic |
| Genotoxicity (Mouse Lymphoma Assay) | Non-mutagenic | Pass - non-mutagenic | |
| Systemic Toxicity (ISO Study in Mice) | Non-toxic | Pass - non-toxic | |
| Intracutaneous (ISO Study in Rabbits) | Non-irritant | Pass - non-irritant | |
| Sensitization (ISO Guinea Pig Maximization) | Non-sensitizing | Pass - non-sensitizing | |
| Mouse Peripheral Blood Micronucleus Study | No micronuclei | Pass - no micronuclei in mice | |
| Bacterial Reverse Mutation Study | Non-mutagenic | Pass - non-mutagenic | |
| Rabbit Pyrogen (USP Material Mediated) | Non-pyrogen | Pass - non-pyrogen | |
| Material Testing | Tensile Strength (compared to predicate devices: Unite Biomatrix and Oasis Wound Matrix) | Equivalent or stronger than predicate devices | Equivalent to Unite Biomatrix, significantly stronger than Oasis Wound Matrix (non-fenestrated and fenestrated comparable to non-fenestrated BriDGE ECM and stronger than Oasis non-fenestrated) |
| Suture Pull-Out Testing (compared to predicate devices) | Equivalent to predicate devices | Equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the exact sample sizes for each of the performance and biocompatibility studies. The studies are described as "A study" or "Complete biocompatibility studies," indicating that samples were used, but the specific number of units, animals, or specimens is not detailed.
- Data Provenance: The biocompatibility studies were conducted by NAmSA under Good Laboratory Practices (GLP) in accordance with ISO 10993 standards. The material testing (tensile strength and suture pull-out) was conducted presumably by or for Harbor MedTech, Inc. The document does not specify the country of origin of the data beyond mentioning NAmSA as the testing facility. All studies described are preclinical studies, implying they were conducted in a controlled lab environment rather than on human subjects. They are prospective in nature, designed specifically to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies described are preclinical performance and biocompatibility tests, not studies that require expert-established ground truth in the context of medical imaging or clinical diagnostics. The "ground truth" here is defined by objective laboratory measurements and standardized biological responses, as determined by the GLP-adhering personnel at NAmSA and in material testing labs.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews to resolve disagreements, which is not relevant to laboratory-based material or biocompatibility testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. The device described is a wound dressing, not an AI-powered diagnostic or imaging tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical wound dressing, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for the performance testing includes:
- Standardized biological responses: For biocompatibility tests (e.g., cell viability for cytotoxicity, mutation rates for genotoxicity, inflammatory responses for irritation/sensitization). These are established by international standards (ISO 10993, OECD Test No. 474) and assessed under GLP conditions.
- Objective physical measurements: For material testing (e.g., peak load in Newtons for tensile strength and suture pull-out). These are quantitative measurements against established material properties.
- Predicate device comparison: The performance of the BriDGE ECM was directly compared to the performance of legally marketed predicate devices (Unite™ Biomatrix and Oasis Wound Dressing) to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical wound dressing and does not involve AI or machine learning, thus no "training set" in the computational sense is used. The manufacturing process and formulation could be considered "trained" through iterative development, but this is not quantifiable as a typical training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
N/A